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The FDA was pretty busy during the month of September, issuing 7 Warning Letters. What is the FDA you might ask? The acronym FDA stands for United States Food and Drug Administration. As the name suggests, they regulate Foods and Drugs in the United States. They create regulations that help keep us safe and enforce resolving violations in companies that might be putting us in harms way. The FDA offers preventative services such as routine testing and monitoring food-based companies and operates as an investigative service when a foodborne outbreak is identified. They are kind of like the batman of the food industry. Quietly lurking in the shadows until help is needed.
One of the tools the FDA holds in their proverbial tool belt is an official “Warning Letter.” A Warning Letter is an official and public notice that is used when a manufacturer has “significantly violated FDA regulations.” A Warning Letter identifies the violation. This could be anywhere from poor manufacturing practices to routine problems found at the manufacturing facility, improper claims, or even incorrect directions for use. This official notice makes it clear that the company must fix their problems and provides both directions and a timeline that the company will inform the FDA of how they will go about doing it. The FDA will make sure that the proposed corrections meet the FDA’s expectations. In short, it is a “fix this or else” communication. Failure to comply will result in the FDA shutting down the facility.
When I say that 7 food companies received such notices in a short time period, this alarms me. It takes quite a bit to get this far. Some of the names that came up are new. Others are repeat offenders.
Elwood International, Inc
Elwood International, Inc of Copiague, New York was issued a Warning Letter September 27, 2018. Elwood International is a manufacturer of condiments and sauces. In addition to FDA samples of Elwood’s Fat-Free Low Sodium Ranch Dressing Artificial Flavor packaged in hermetically-sealed containers that the firm ships in unrefrigerated containers testing above pH 4.6 and containing water activity over 0.85, staff participating in the manufacture of food products did not complete approved courses that would allow them to legally work in the facility.
This was not the end of their infractions. Their Warning Letter issued remarks on 8 different violations, including:
Vinill, Inc of Brooklyn, New York was issued a Warning Letter on September 21, 2018. Vinill is a seafood processing and distribution facility. The major violation that renders the refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish unsafe for consumption is failure to conduct a hazard analysis for each kind of fish or fishery product to determine potential food safety hazards that are likely to occur and implement a written HACCP plan to control any potential food safety hazards that might occur.
Best Nutrition Products, Inc.
Best Nutrition Products, Inc of Hayward, California was issued a Warning Letter on September 7, 2018. Best Nutrition Products manufactures dietary supplements. In addition to selling “unapproved new” or “misbranded” drugs that provide health claims not approved by the FDA and bears inadequate directions for its intended use without the safe administration by a licensed medical practitioner, the following violations were observed:
Rose Acre Farms, Inc.
Rose Acre Farms, Inc of Seymour, Indiana was issued a Warning Letter on September 6, 2018. Rose Acre Farms is a shell egg farm and processing plant. If this name sounds familiar, it should. This is the same farm that was linked to a Salmonella outbreak that sickened 45 people across 10 states that prompted the largest egg recall since 2010. The same problems persist, prompting another Warning Letter from the FDA. In addition to unacceptable rodent activity, samples from many areas around the processing plant and farm were positive for Salmonella Braenderup and Salmonella Heidelberg. Other unsanitary and poor employee practices were observed, including:
Samuel Zimmerman of Penn Yan, New York was issued a Warning Letter on September 5, 2018. Samuel Zimmerman is responsible for a shell egg farm. The farm is in violation for not implementing a written Salmonella Enteritidis prevention plan as required by the FDA in addition to other violations, including:
Environmental Trade Inc.
Environmental Trade, Inc , of Eatonton, Georgia was issued a Warning Letter on September 4, 2018. Environmental Trade manufacturers Blue Ridge Cat products. Following the death of two kittens who consumed Blue Ridge Beef Kitten Grind for Cats, necropsy samples tested positive for Salmonella. This Salmonella matched samples taken from an unopened package of that cat food, linking Environmental Trade to the kittens’ deaths. Additional sampling uncovered Listeria monocytogenes in the package as well. This prompted an inspection of the facility were additional samples tested positive for Salmonella and Listeria monocytogenes. The firm indicated after previous investigations that an antimicrobial additive was used to minimize risk. This additive is not effective and not regulated as acceptable by the FDA.
Natural Sea Products, Co.
Natural Sea Products Co., of Thailand was issued a Warning Letter on September 4, 2018. Natural Sea Product is a Seafood Processing Facility. An inspection of the facility revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations required by the FDA. Additional violations include:
The FDA will continue to monitor responses to these Warning Letters. Personally, I hope that issues resolve before an unfortunate outbreak and costly recall is required. It is in everyone’s best interest for companies to comply.
By: Heather Van Tassell, Contributing Writer (Non-Lawyer)